DJO SURGICAL 346-10-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00190446269779), received between Sep 14, 2020 and Jan 19, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

1 other recall cover devices cleared under the same FDA submission (K180930); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY - DUE TO LOOSENING.

  Patient problems: Joint Laxity

  MAUDE report 24112141 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO PATIENT RUPTURED PATELLA TENDON. SURGEON FIXED THE RUPTURE & WANTED TO REPLACE THE INSERT.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 16587419 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT'S KNEE WAS INFECTED. SURGEON WASHED THE KNEE OUT AND REPLACED THE INSERT.

  Patient problems: Medical device site infection

  MAUDE report 15446815 ↗
• InjuryDec 6, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - REMOVAL OF SCAR TISSUE AND LINER EXCHANGE.

  Patient problems: Scar Tissue

  MAUDE report 12936967 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11435663 ↗
• InjurySep 14, 2020Material Rupture; Unstable

  REVISION SURGERY - PATIENT COMPLAINED OF INSTABILITY IN KNEE. UPON SEEING THE EVIDENCE OF PATELLAR TENDON RUPTURE. SURGEON ENSURED FOR PATELLA TENDON RECONSTRUCTION (POLY INSERT AND NEW PATELLA WERE IMPLANTED).

  Patient problems: No Code Available

  MAUDE report 10528937 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180930. One submission often covers many models, so check the product and lot details in each record.

• Z-1187-2023 · Dec 22, 2022 · Open, Classified
  EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22